Clinical Evaluator (20-40%)

작업 내용

For our medical device client in Bülach we’re actively looking for a Clinical Evaluator (20-40%) for the Medical Affairs (Clinical Science) department.

Please note that the workload is set to 20-40% (1-2 days per week) and you can work up to +80% remote!

The position needs to be filled as soon as possible and is initially limited until November 2022, whereby a prolongation is possible.

Your Responsibilities:

• Develop, revise and review clinical strategies/ clinical evaluation plans, clinical evaluation reports, PMCF plans and reports, summaries of safety and clinical performance and clinical investigator brochures. The documents are submitted to regulatory authorities and notified bodies
• Manage the quality, accuracy, and timely production of reports/ plans
• Perform literature searches/reviews as necessary to obtain and maintain up to date knowledge for the development of documents and for providing subject matter expertise to other departments
• Support risk management activities like development and maintenance of product risk analyses and benefit-risk assessments
• Act as a core team member for product development projects
• Interfaces with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing

Your Profile:

• MD or PhD ideally in the field of Cardiovascular Science
• 2-5 years of experience in medical writing preferably in a similar industry including clinical study reports and protocols, as well as a proven track record of publications in peer reviewed journals as the main author
• Experience in clinical evaluation (CER, PMCF Plan, CEP, etc)
• Excellent presentation and moderation skills, including technical editing and QC skills
• Good understanding of statistics, together with the ability to interpret complex clinical data
• Team oriented, accurate and self-dependent personality with an analytical working style
• Knowledge of MEDDEV 2.7/1 rev. 4 and MDR
• Excellent command of spoken and written English